The development and commercialization of biosimilars require a significant investment in capital, resources, and time. Biosimilars developers must ensure that they are equipped with the necessary expertise in development and manufacturing capabilities. With the number of approved biosimilars constantly increasing, the biopharmaceutical space is set to become more competitive for both innovator and biosimilars companies. As such, it is paramount that biosimilars and innovator companies have well-defined strategies to maximize their competitiveness. In this content, we assess strategies—based on actual practices—that companies can use to flourish in competitive global markets.

The product profiles of the biosimilars that have launched or will soon enter the major markets (United States, EU5, and Japan) are included in the section “Biosimilars Profiles.” These profiles include information about the biosimilars developer(s) and marketer(s), regulatory timelines, development history, approved indications, summary of clinical development, and position in the market.

Questions answered in this report:

  • How have biosimilars developers achieved success in the biosimilars market?
  • What options are available to biosimilars developers that lack in-house manufacturing capabilities?
  • What factors should biosimilars developers consider when designing clinical programs for biosimilar agents?
  • How can biosimilars and reference-brand companies exploit the multifactorial decision-making process used by stakeholders to differentiate their product from the competition?
  • What types of data do physicians require to increase their use of biosimilars in biologic-treated patients?
  • What options are available to reference-brand companies seeking to defend against biosimilar entry?

Key markets covered:

  • Global

Key companies mentioned:

  • AbbVie
  • Amgen
  • Biocon
  • Biogen
  • Boehringer Ingelheim
  • Celltrion
  • Coherus Biosciences
  • Eli Lilly
  • Halozyme
  • Hospira
  • Merck & Co.
  • Mylan
  • Novartis
  • Pfizer
  • Roche
  • Samsung Bioepis
  • Sandoz
  • Sanofi
  • Teva

Key drugs mentioned:

  • Abasaglar/Basaglar
  • Amjevita/Amgevita/Solymbic
  • Avastin
  • Benepali
  • Binocrit
  • Cyltezo
  • Enbrel
  • Erelzi
  • Flixabi
  • Herceptin
  • Humira
  • Imraldi
  • Inflectra
  • Mvasi
  • Neulasta
  • Nivestim
  • Remicade
  • Remsima
  • Renflexis
  • Rituxan/MabThera
  • Rixathon/Riximyo
  • Truxima
  • Zarzio/Zarxio

Table of contents

  • Biosimilar Developer Strategies
    • Introduction
    • Biosimilar Target Selection
      • Alignment with Existing and Pipeline Portfolios
      • Commercial Opportunity
      • Case Study: Commercial Opportunity and Portfolio-Alignment Considerations for Targeting Insulins
      • Case Study: Realigning Company Strategy
    • Partnering
      • Development and Manufacturing Strategies for Biosimilars
        • Case Study: CRO Syneos Health as a Biosimilars Clinical Development Partner
        • Case Studies: Dissolved Partnerships due to High Development Burden for Biosimilars
      • Biosimilars Regulatory and Marketing Strategies
        • Case Studies: Biocon's and Mylan's Global Partnership Strategies
        • Case Study: Celltrion's Global Partnership Strategy
        • Case Study: Prestige Biopharma's Global Partnership Strategy
        • Case Studies: Strategies Compromised by the Acquisition or Partnering of a Biosimilars Developer
      • Joint Ventures Focusing on Biosimilars
        • Summary
        • Case Studies: Successful and Promising Joint Ventures Developing and Marketing Biosimilars
    • Manufacturing
      • Summary
      • Use of Different Manufacturing Techniques
      • Benefits of New Manufacturing Techniques
    • Clinical Development
      • Clinical Development Burden for Biosimilars
        • Summary
      • Trial Population
        • Regulatory Considerations
        • Commercial Considerations
        • Recruitment Considerations
      • Number of Trials
        • Satisfying Multiple Regulatory Agencies
        • Case Study: Difficulties Developing Cetuximab Biosimilars
        • Trials in Multiple Indications
        • Case Study: Indication Extrapolation for Biosimilars of Bevacizumab
        • Case Study: Omitting a Phase III Randomized Trial
      • Positive Differentiation Through Clinical Data
        • Production of Switching Data
        • Improving Mode of Administration
        • Improving on Excipients Used
        • Improving the Drug Device
        • Improving Stability and Storage
        • Improving Presentation
      • Geography Development
      • Postapproval Surveillance and Studies
      • Case Study: Remsima/Inflectra as the First Monoclonal Antibody Approved in the Major Markets
        • The EMA's Review of CT-P13 in Europe
        • The FDA's Review of CT-P13 in the United States
        • The MHLW's Review of CT-P13 in Japan
    • Regulatory and Intellectual Property Considerations
      • U.S. Dossier Disclosure to the Sponsor of the Reference Product
      • Case Study: Sandoz's Litigation with Amgen for Its Filgrastim Biosimilar Zarxio
    • Marketing
      • Marketing of a Biosimilar vs. the Reference Brand
        • Physician and Payer Opinions of the Drivers of and Constraints to Biosimilar Uptake
        • Marketing of Hospital-Administered Biosimilars vs. the Reference Brand
        • Marketing Biosimilars vs. the Reference Brand in the Retail and Outpatient Setting
      • Marketing of a Biosimilar vs. Other Available Biosimilars
        • Leveraging Trust
        • Device Differentiation
        • Securing a Superior Label
        • Case Study: Indication Extrapolation for Biosimilars ESAs
        • Differentiation Through Value-Added Services and Support
        • Case Study: Zarzio's Performance in Europe
      • Improving the Understanding of Biosimilars Across Key Stakeholders
        • Greater Physician Comfort with Biosimilars
        • Educational Campaigns
    • Pricing
      • United States
      • Europe
      • Japan
      • Emerging Markets
    • Key Biosimilars Developer Profiles

Author(s): Marta Delgado, PhD; Jimmy Jacob

Marta Delgado, is a Business Insight Analyst in the Biosimilars Research team, responsible for the analysis of the biosimilars market across four main therapeutic areas – oncology, endocrinology, immunology and nephrology. Marta holds a in Molecular Neuroscience from University College of London (UCL) and a in Biomedicine from University Pompeu Fabra (UPF), Barcelona. Prior to joining the Biosimilars Research team, Marta worked as a Research Analyst at SKIM, specialising in advanced quantitative studies assessing the potential market opportunities to support life sciences companies in their business decision making.

Jimmy Jacob, is a Business Insights Analyst in the Biosimilars team. Prior to joining DRG, Jimmy worked as a Scientist in Medimmune and Horizon Discovery mostly involving CRIPSR/Cas9 therapeutics. He received his master’s degree in Biotechnology from University of Dundee and his from Imperial College London. His work involved identifying novel molecules that regulated oestrogen receptor-alpha in breast cancer.